AzTrials
AzTrials

DiabetesPhase 3LEADER®NCT01179048

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 428 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,341 participants
Where
428 sitesin 33 countries
Study dates
31 Aug 2010to 17 Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion

Trial locations and contacts

428 sites in 33 countries.

428 sites in 33 countries

United States125 sites

  • Novo Nordisk Investigational Site

    Alabaster, Alabama, 35007

  • Novo Nordisk Investigational Site

    Albany, New York, 12208

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania, 16602

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76014

  • Novo Nordisk Investigational Site

    Asheville, North Carolina, 28801

  • Novo Nordisk Investigational Site

    Aurora, Colorado, 80045-7402

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21204

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21218-2829

  • Novo Nordisk Investigational Site

    Bartlett, Tennessee, 38133

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009-1957

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35209

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35294

  • Novo Nordisk Investigational Site

    Bloomfield Hills, Michigan, 48302

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Buffalo, New York, 14221-7091

  • Novo Nordisk Investigational Site

    Burlington, North Carolina, 27215

  • Novo Nordisk Investigational Site

    Cadiz, Ohio, 43907

  • Novo Nordisk Investigational Site

    Cerritos, California, 90703-2115

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina, 27517

  • Novo Nordisk Investigational Site

    Charleston, South Carolina, 29455

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60612

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60654

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45219

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45220-2213

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33756

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44106

  • Novo Nordisk Investigational Site

    Columbia, South Carolina, 29203

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois, 60012

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390

  • Novo Nordisk Investigational Site

    Dearborn, Michigan, 48124

  • Novo Nordisk Investigational Site

    DeLand, Florida, 32724

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80220

  • Novo Nordisk Investigational Site

    Escondido, California, 92025

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33316

  • Novo Nordisk Investigational Site

    Fresno, California, 93721-1443

  • Novo Nordisk Investigational Site

    Great Falls, Montana, 59405

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27401

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Greenville, South Carolina, 29607

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Hatfield, Pennsylvania, 19440

  • Novo Nordisk Investigational Site

    Houston, Texas, 77070

  • Novo Nordisk Investigational Site

    Houston, Texas, 77095

  • Novo Nordisk Investigational Site

    Huntsville, Alabama, 35801

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46260-1992

  • Novo Nordisk Investigational Site

    Interlochen, Michigan, 49643

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34744

  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia, 30046

  • Novo Nordisk Investigational Site

    Lebanon, New Hampshire, 03756

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40502

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72205-5446

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72205

  • Novo Nordisk Investigational Site

    Longview, Texas, 75605

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90017-4006

  • Novo Nordisk Investigational Site

    Los Banos, California, 93635

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40202

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40206

  • Novo Nordisk Investigational Site

    Lubbock, Texas, 79423

  • Novo Nordisk Investigational Site

    Madison, Wisconsin, 53717

  • Novo Nordisk Investigational Site

    Marion, Ohio, 43302

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38163

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70006-2930

  • Novo Nordisk Investigational Site

    Miami, Florida, 33136

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Middleburg Heights, Ohio, 44310

  • Novo Nordisk Investigational Site

    Mine Hill, New Jersey, 07803

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota, 55416

  • Novo Nordisk Investigational Site

    Mission Hills, California, 91345

  • Novo Nordisk Investigational Site

    Mobile, Alabama, 36608

  • Novo Nordisk Investigational Site

    Monroe, Louisiana, 71203

  • Novo Nordisk Investigational Site

    Monroe, North Carolina, 28110

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Mooresville, North Carolina, 28117

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Murrells Inlet, South Carolina, 29576

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina, 29572

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37212

  • Novo Nordisk Investigational Site

    Natchitoches, Louisiana, 71457-5881

  • Novo Nordisk Investigational Site

    Neptune City, New Jersey, 07753-4859

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana, 70112

  • Novo Nordisk Investigational Site

    New York, New York, 10032

  • Novo Nordisk Investigational Site

    New York, New York, 10036

  • Novo Nordisk Investigational Site

    New York, New York, 10065

  • Novo Nordisk Investigational Site

    Newark, Delaware, 19713

  • Novo Nordisk Investigational Site

    Odessa, Texas, 79761

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73103

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68105

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32804

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84102

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78228-3419

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    Schertz, Texas, 78154

  • Novo Nordisk Investigational Site

    Smithtown, New York, 11787

  • Novo Nordisk Investigational Site

    South Burlington, Vermont, 05403

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99210

  • Novo Nordisk Investigational Site

    Springfield, Missouri, 65807

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63108

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida, 33711

  • Novo Nordisk Investigational Site

    Syracuse, New York, 13210

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33624

  • Novo Nordisk Investigational Site

    Tempe, Arizona, 85283

  • Novo Nordisk Investigational Site

    Tomball, Texas, 77375

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48085-5524

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Uniontown, Pennsylvania, 15401

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Watsonville, California, 95076

  • Novo Nordisk Investigational Site

    West Des Moines, Iowa, 50265

  • Novo Nordisk Investigational Site

    West Palm Beach, Florida, 33409

  • Novo Nordisk Investigational Site

    Westfield, New York, 14787

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina, 28472

Other trials in United States

Brazil35 sites

  • Novo Nordisk Investigational Site

    Aparecida de Goiânia, Goiás, 74935-530

  • Novo Nordisk Investigational Site

    Aracajú, 49020-270

  • Novo Nordisk Investigational Site

    Belém, Pará, 66073-000

  • Novo Nordisk Investigational Site

    Belo Horizonte, 30150-221

  • Novo Nordisk Investigational Site

    Campinas, São Paulo, 13059-740

  • Novo Nordisk Investigational Site

    Campinas, São Paulo, 13073-350

  • Novo Nordisk Investigational Site

    Campinas, 13084-971

  • Novo Nordisk Investigational Site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80010-030

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80030-110

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80810-040

  • Novo Nordisk Investigational Site

    Curitiba, 80420-011

  • Novo Nordisk Investigational Site

    Fortaleza, Ceará, 60115-282

  • Novo Nordisk Investigational Site

    Fortaleza, Ceará, 60170-001

  • Novo Nordisk Investigational Site

    Fortaleza, Ceará, 60192-340

  • Novo Nordisk Investigational Site

    Fortaleza, 60430-350

  • Novo Nordisk Investigational Site

    Goiânia, 74110-120

  • Novo Nordisk Investigational Site

    Joinville, 05001-100

  • Novo Nordisk Investigational Site

    Marília, 17519-000

  • Novo Nordisk Investigational Site

    Mogi das Cruzes, São Paulo, 08780-090

  • Novo Nordisk Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Novo Nordisk Investigational Site

    Porto Alegre, 90035-170

  • Novo Nordisk Investigational Site

    Recife, 52020-010

  • Novo Nordisk Investigational Site

    Rio de Janeiro, 20211-340

  • Novo Nordisk Investigational Site

    Rio de Janeiro, 20551-030

  • Novo Nordisk Investigational Site

    Santos, 11045-904

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01223-001

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-000

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-200

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 04012-909

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 04020-041

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 05403-000

  • Novo Nordisk Investigational Site

    São Paulo, 01323-001

  • Novo Nordisk Investigational Site

    São Paulo, 04011-030

  • Novo Nordisk Investigational Site

    São Paulo, 05403-000

Other trials in Brazil

Germany24 sites

  • Novo Nordisk Investigational Site

    Angermünde/OT Wolletz, 16278

  • Novo Nordisk Investigational Site

    Aschaffenburg, 63739

  • Novo Nordisk Investigational Site

    Berlin, 12163

  • Novo Nordisk Investigational Site

    Berlin, 13055

  • Novo Nordisk Investigational Site

    Dillingen, 89407

  • Novo Nordisk Investigational Site

    Dresden, 01219

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910

  • Novo Nordisk Investigational Site

    Essen, 45219

  • Novo Nordisk Investigational Site

    Falkensee, 14612

  • Novo Nordisk Investigational Site

    Gifhorn, 38518

  • Novo Nordisk Investigational Site

    Hamburg, 22587

  • Novo Nordisk Investigational Site

    Karlsbad, 76307

  • Novo Nordisk Investigational Site

    Leipzig, 04103

  • Novo Nordisk Investigational Site

    Leipzig, 04275

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059

  • Novo Nordisk Investigational Site

    Mannheim, 68163

  • Novo Nordisk Investigational Site

    München, 80336

  • Novo Nordisk Investigational Site

    Oldenburg, 23758

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386

  • Novo Nordisk Investigational Site

    Schkeuditz, 04435

  • Novo Nordisk Investigational Site

    Schweinfurt, 97421

  • Novo Nordisk Investigational Site

    Ulm, 89081

  • Novo Nordisk Investigational Site

    Villingen-Schwenningen, 78048

  • Novo Nordisk Investigational Site

    Wangen, 88239

Other trials in Germany

United Kingdom20 sites

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 1LD

  • Novo Nordisk Investigational Site

    Birmingham, B9 5SS

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX

  • Novo Nordisk Investigational Site

    Devon, EX2 5DW

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY

  • Novo Nordisk Investigational Site

    Edinburgh, EH16 4SA

  • Novo Nordisk Investigational Site

    Glasgow, G31 2ER

  • Novo Nordisk Investigational Site

    Guildford, GU2 7XX

  • Novo Nordisk Investigational Site

    Hull, HU3 2RW

  • Novo Nordisk Investigational Site

    Livington, EH54 6PP

  • Novo Nordisk Investigational Site

    London, W2 1NY

  • Novo Nordisk Investigational Site

    Manchester, M6 8HD

  • Novo Nordisk Investigational Site

    Norwich, NR4 7TJ

  • Novo Nordisk Investigational Site

    Nuneaton, CV10 7DJ

  • Novo Nordisk Investigational Site

    Plymouth, PL6 8BQ

  • Novo Nordisk Investigational Site

    St Helens, WA9 3DA

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL

  • Novo Nordisk Investigational Site

    Torquay, TQ2 7AA

  • Novo Nordisk Investigational Site

    West Midlands, B71 4HJ

Other trials in United Kingdom

Canada18 sites

  • Novo Nordisk Investigational Site

    Cambridge, Ontario, N1R 7L6

  • Novo Nordisk Investigational Site

    Cornwall, Ontario, K6H 4M4

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T5J 3N4

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novo Nordisk Investigational Site

    London, Ontario, N6A 4V2

  • Novo Nordisk Investigational Site

    London, Ontario, N6G 2M1

  • Novo Nordisk Investigational Site

    Mississauga, Ontario, L5M 2V8

  • Novo Nordisk Investigational Site

    Montreal, Quebec, H2W 1R7

  • Novo Nordisk Investigational Site

    Québec, G1V 4G2

  • Novo Nordisk Investigational Site

    Québec, G1V 4G5

  • Novo Nordisk Investigational Site

    Scarborough Village, Ontario, M1E 5E9

  • Novo Nordisk Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • Novo Nordisk Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Novo Nordisk Investigational Site

    Thunder Bay, Ontario, P7A 4V7

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5C 2T2

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M5T 3L9

  • Novo Nordisk Investigational Site

    Vancouver, British Columbia, V6H 3X8

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

India18 sites

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560 003

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560043

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560052

  • Novo Nordisk Investigational Site

    Chandigarh, Punjab, 160012

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600029

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600086

  • Novo Nordisk Investigational Site

    Guwahati, Assam, 781007

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500034

  • Novo Nordisk Investigational Site

    Hyderbad, Andhra Pradesh, 500 012

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh, 452010

  • Novo Nordisk Investigational Site

    Karnāl, Haryana, 132001

  • Novo Nordisk Investigational Site

    Kochi, Kerala, 682041

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700054

  • Novo Nordisk Investigational Site

    Madurai, Tamil Nadu, 625 020

  • Novo Nordisk Investigational Site

    Manipal, Karnataka, 576104

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400012

  • Novo Nordisk Investigational Site

    Thriruvananthapuram, 695 032

  • Novo Nordisk Investigational Site

    Vellore, Tamil Nadu, 632004

Other trials in India

South Africa16 sites

  • Novo Nordisk Investigational Site

    Alberton, 1449

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State, 9301

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape

  • Novo Nordisk Investigational Site

    Cape Town, 7530

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4091

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4126

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4320

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1829

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2013

  • Novo Nordisk Investigational Site

    Lenasia, Gauteng, 1827

  • Novo Nordisk Investigational Site

    Midrand, Gauteng, 1685

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0001

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0083

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0181

  • Novo Nordisk Investigational Site

    Somerset West, Western Cape, 7130

  • Novo Nordisk Investigational Site

    Tongaat, KwaZulu-Natal, 4400

Other trials in South Africa

Turkey (Türkiye)16 sites

  • Novo Nordisk Investigational Site

    Ankara, 06100

  • Novo Nordisk Investigational Site

    Ankara, 06500

  • Novo Nordisk Investigational Site

    Antalya, 07058

  • Novo Nordisk Investigational Site

    Bursa, 16059

  • Novo Nordisk Investigational Site

    Gaziantep, 27070

  • Novo Nordisk Investigational Site

    Istanbul, 34096

  • Novo Nordisk Investigational Site

    Istanbul, 34098

  • Novo Nordisk Investigational Site

    Istanbul, 34360

  • Novo Nordisk Investigational Site

    Istanbul, 34371

  • Novo Nordisk Investigational Site

    Istanbul, 34390

  • Novo Nordisk Investigational Site

    Istanbul, 34722

  • Novo Nordisk Investigational Site

    Istanbul, 34890

  • Novo Nordisk Investigational Site

    Istanbul

  • Novo Nordisk Investigational Site

    Izmir, 35100

  • Novo Nordisk Investigational Site

    Izmir, 35340

  • Novo Nordisk Investigational Site

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Russia14 sites

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163001

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045

  • Novo Nordisk Investigational Site

    Barnaul, 656045

  • Novo Nordisk Investigational Site

    Kazan', 420043

  • Novo Nordisk Investigational Site

    Moscow, 117036

  • Novo Nordisk Investigational Site

    Moscow, 119435

  • Novo Nordisk Investigational Site

    Moscow, 125367

  • Novo Nordisk Investigational Site

    Moscow, 127486

  • Novo Nordisk Investigational Site

    Nizhny Novgorod, 603126

  • Novo Nordisk Investigational Site

    Penza, 440026

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Smolensk, 214019

  • Novo Nordisk Investigational Site

    Tyumen, 625023

  • Novo Nordisk Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Poland13 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-435

  • Novo Nordisk Investigational Site

    Bydgoszcz, 85-822

  • Novo Nordisk Investigational Site

    Katowice, 40-084

  • Novo Nordisk Investigational Site

    Krakow, 31-261

  • Novo Nordisk Investigational Site

    Krakow, 31-271

  • Novo Nordisk Investigational Site

    Krakow, 31-501

  • Novo Nordisk Investigational Site

    Lodz, 93-338

  • Novo Nordisk Investigational Site

    Poznan, 60-569

  • Novo Nordisk Investigational Site

    Puławy, 24-100

  • Novo Nordisk Investigational Site

    Ruda Śląska, 41-709

  • Novo Nordisk Investigational Site

    Warsaw, 01-192

  • Novo Nordisk Investigational Site

    Warsaw, 02-507

  • Novo Nordisk Investigational Site

    Wroclaw, 50-381

Other trials in Poland

Italy11 sites

  • Novo Nordisk Investigational Site

    Bologna, 40138

  • Novo Nordisk Investigational Site

    Catanzaro, 88100

  • Novo Nordisk Investigational Site

    Chieti, 66100

  • Novo Nordisk Investigational Site

    Florence, 50141

  • Novo Nordisk Investigational Site

    Latina, 04100

  • Novo Nordisk Investigational Site

    Lucca, 55100

  • Novo Nordisk Investigational Site

    Milan, 20132

  • Novo Nordisk Investigational Site

    Padova, 35128

  • Novo Nordisk Investigational Site

    Palermo, 90127

  • Novo Nordisk Investigational Site

    Roma, 00133

  • Novo Nordisk Investigational Site

    Roma, 00161

Other trials in Italy

Spain11 sites

  • Novo Nordisk Investigational Site

    A Coruña, 15006

  • Novo Nordisk Investigational Site

    Almería, 04001

  • Novo Nordisk Investigational Site

    Barcelona, 08036

  • Novo Nordisk Investigational Site

    Madrid, 28040

  • Novo Nordisk Investigational Site

    Mora de Ebre, 43740

  • Novo Nordisk Investigational Site

    Mostoles - Madrid -, 28935

  • Novo Nordisk Investigational Site

    Palma de Mallorca, 07198

  • Novo Nordisk Investigational Site

    Pozuelo de Alarcón, 28223

  • Novo Nordisk Investigational Site

    Seville, 41003

  • Novo Nordisk Investigational Site

    Seville, 41014

  • Novo Nordisk Investigational Site

    Valladolid, 47005

Other trials in Spain

Australia10 sites

  • Novo Nordisk Investigational Site

    Blacktown, New South Wales, 2148

  • Novo Nordisk Investigational Site

    Box Hill, Victoria, 3128

  • Novo Nordisk Investigational Site

    Douglas, Queensland, 4814

  • Novo Nordisk Investigational Site

    Fitzroy, Victoria, 3065

  • Novo Nordisk Investigational Site

    Fremantle, Western Australia, 6160

  • Novo Nordisk Investigational Site

    Herston, Queensland, 4029

  • Novo Nordisk Investigational Site

    Hobart, Tasmania, 7000

  • Novo Nordisk Investigational Site

    Keswick, South Australia, 5035

  • Novo Nordisk Investigational Site

    Meadowbrook, Queensland, 4131

  • Novo Nordisk Investigational Site

    Oaklands Park, South Australia, 5046

Other trials in Australia

Romania10 sites

  • Novo Nordisk Investigational Site

    Bacau, 600114

  • Novo Nordisk Investigational Site

    Bucharest, 020475

  • Novo Nordisk Investigational Site

    Constanța, 900591

  • Novo Nordisk Investigational Site

    Craiova, Dolj, 200642

  • Novo Nordisk Investigational Site

    Deva, 330084

  • Novo Nordisk Investigational Site

    Iași, 700547

  • Novo Nordisk Investigational Site

    Satu Mare, 440055

  • Novo Nordisk Investigational Site

    Sibiu, 550245

  • Novo Nordisk Investigational Site

    Târgu Mureş, Mureș County, 540098

  • Novo Nordisk Investigational Site

    Timișoara, Timiș County, 300736

Other trials in Romania

Netherlands9 sites

  • Novo Nordisk Investigational Site

    Amsterdam, 1066 EC

  • Novo Nordisk Investigational Site

    Eindhoven, 5631 BM

  • Novo Nordisk Investigational Site

    Etten-Leur, 4872 LP

  • Novo Nordisk Investigational Site

    Goes, 4461 LT

  • Novo Nordisk Investigational Site

    Groningen, 9728 NT

  • Novo Nordisk Investigational Site

    Hoogeveen, 7909 AA

  • Novo Nordisk Investigational Site

    Maastricht, 6229 HX

  • Novo Nordisk Investigational Site

    Nijmegen, 6525 GA

  • Novo Nordisk Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

China8 sites

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100044

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100730

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100853

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong, 510120

  • Novo Nordisk Investigational Site

    Qingdao, Shandong, 266003

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai Municipality, 200003

  • Novo Nordisk Investigational Site

    Xiamen, Fujian, 361003

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu, 212001

Other trials in China

Mexico8 sites

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Durango, 34000

  • Novo Nordisk Investigational Site

    Durango, 34080

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44600

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44650

  • Novo Nordisk Investigational Site

    Monterrey, 64460

  • Novo Nordisk Investigational Site

    San Luis Potosí City, 78200

  • Novo Nordisk Investigational Site

    Tijuana, Baja California Norte, 22010

Other trials in Mexico

Denmark6 sites

  • Novo Nordisk Investigational Site

    Aalborg, 9100

  • Novo Nordisk Investigational Site

    Århus C, 8000

  • Novo Nordisk Investigational Site

    Esbjerg, 6700

  • Novo Nordisk Investigational Site

    Gentofte Municipality, 2820

  • Novo Nordisk Investigational Site

    Hvidovre, 2650

  • Novo Nordisk Investigational Site

    Odense, 5000

Other trials in Denmark

Sweden6 sites

  • Novo Nordisk Investigational Site

    Gothenburg, 413 45

  • Novo Nordisk Investigational Site

    Malmö, 205 02

  • Novo Nordisk Investigational Site

    Örebro, 701 85

  • Novo Nordisk Investigational Site

    Stockholm, 111 57

  • Novo Nordisk Investigational Site

    Stockholm, 113 24

  • Novo Nordisk Investigational Site

    Stockholm, 141 86

Other trials in Sweden

Austria5 sites

  • Novo Nordisk Investigational Site

    Graz, 8036

  • Novo Nordisk Investigational Site

    Vienna, 1030

  • Novo Nordisk Investigational Site

    Vienna, 1090

  • Novo Nordisk Investigational Site

    Vienna, 1130

  • Novo Nordisk Investigational Site

    Vienna, 1140

Other trials in Austria

Finland5 sites

  • Novo Nordisk Investigational Site

    Kuopio, 70210

  • Novo Nordisk Investigational Site

    Lahti, 15110

  • Novo Nordisk Investigational Site

    Oulu, 90220

  • Novo Nordisk Investigational Site

    Tampere, 33520

  • Novo Nordisk Investigational Site

    Vantaa, FIN-01600

Other trials in Finland

Israel5 sites

  • Novo Nordisk Investigational Site

    Haifa, 31096

  • Novo Nordisk Investigational Site

    Haifa, 35152

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Petah Tikva, 49372

  • Novo Nordisk Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

Norway5 sites

  • Novo Nordisk Investigational Site

    Oslo, 0407

  • Novo Nordisk Investigational Site

    Oslo, 0586

  • Novo Nordisk Investigational Site

    Stavanger, 4011

  • Novo Nordisk Investigational Site

    Tønsberg, 3117

  • Novo Nordisk Investigational Site

    Trondheim, 7030

Other trials in Norway

South Korea5 sites

  • Novo Nordisk Investigational Site

    Goyang, 410-719

  • Novo Nordisk Investigational Site

    Seongnam-si, 463-707

  • Novo Nordisk Investigational Site

    Seoul, 02447

  • Novo Nordisk Investigational Site

    Seoul, 137-701

  • Novo Nordisk Investigational Site

    Seoul, 139-827

Other trials in South Korea

Belgium4 sites

  • Novo Nordisk Investigational Site

    Edegem, 2650

  • Novo Nordisk Investigational Site

    Ghent, 9000

  • Novo Nordisk Investigational Site

    Leuven, 3000

  • Novo Nordisk Investigational Site

    Liège, 4000

Other trials in Belgium

France4 sites

  • Novo Nordisk Investigational Site

    Corbeil-Essonnes, 91106

  • Novo Nordisk Investigational Site

    Jarny, 54800

  • Novo Nordisk Investigational Site

    Nîmes, 30006

  • Novo Nordisk Investigational Site

    Paris, 75877

Other trials in France

Greece4 sites

  • Novo Nordisk Investigational Site

    Athens, GR-10552

  • Novo Nordisk Investigational Site

    Athens, GR-11527

  • Novo Nordisk Investigational Site

    Crete, 71001

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001

Other trials in Greece

Taiwan4 sites

  • Novo Nordisk Investigational Site

    Changhua, 500

  • Novo Nordisk Investigational Site

    Kaoshiung, 807

  • Novo Nordisk Investigational Site

    Tainan, 710

  • Novo Nordisk Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Czechia2 sites

  • Novo Nordisk Investigational Site

    Pilsen, 304 60

  • Novo Nordisk Investigational Site

    Prague, 128 08

Other trials in Czechia

Ireland2 sites

  • Novo Nordisk Investigational Site

    Dublin, DUBLIN 4

  • Novo Nordisk Investigational Site

    Dublin

Other trials in Ireland

Puerto Rico2 sites

  • Novo Nordisk Investigational Site

    Bayamón, 00961

  • Novo Nordisk Investigational Site

    Caguas, 00725

Other trials in Puerto Rico

United Arab Emirates2 sites

  • Novo Nordisk Investigational Site

    Dubai, 4545

  • Novo Nordisk Investigational Site

    Dubai, 7272

Other trials in United Arab Emirates

Serbia1 site

  • Novo Nordisk Investigational Site

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

Being tested
liraglutide, placebo
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liraglutideDrug

    Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

  • placeboDrug

    Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Study groups in NCT01179048
Study groupRoleWhat they receive
LiraglutideExperimentalNot described
Receives: Drug: liraglutide
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

    Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Secondary outcomes (5)

  1. Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.

    Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

  2. Time From Randomisation to All Cause Death

    Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

  3. Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome

    Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

  4. Time From Randomisation to First Occurrence of a Composite Microvascular Outcome

    Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:

    • new onset of persistent macroalbuminuria
    • persistent doubling of serum creatinine
    • need for continuous renal replacement therapy
    • death due to renal disease
    • need for retinal photocoagulation or treatment with intravitreal agents
    • vitreous haemorrhage
    • diabetes-related blindness

    The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

  5. Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.

    Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.

    Measured: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2010 (estimated)
  2. Study start31 Aug 2010
  3. Primary completion17 Dec 2015
  4. Study completion17 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
9,341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01179048
Sponsor's protocol ID
EX2211-3748
Other IDs
2009-012201-19, U1111-1113-7090, CTR20130003, 2009
Acronym
LEADER®
Status last verified
Jul 2019
First submitted
6 Aug 2010
Last updated
17 Jul 2019
Data monitoring committee
Yes

Publications

  • Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.

    PubMed 30851070

  • Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11.

    PubMed 30900349

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, Masmiquel L, Leiter LA, Haluzik M, Satman I, Omar M, Shestakova M, Van Gaal L, Mann JF, Baeres FM, Zinman B, Poulter NR; LEADER investigators. LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.

    PubMed 26855018

  • Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J, Franek E, Raz I, Comlekci A, Jacob S, van Gaal L, Baeres FM, Marso SP, Eriksson M; LEADER investigators. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial. Cardiovasc Diabetol. 2016 Feb 10;15:29. doi: 10.1186/s12933-016-0341-5.

    PubMed 26864124

  • Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Orsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications. 2016 Nov-Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3.

    PubMed 27320184

  • Rutten GE, Tack CJ, Pieber TR, Comlekci A, Orsted DD, Baeres FM, Marso SP, Buse JB; LEADER Investigators. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Diabetol Metab Syndr. 2016 Jun 2;8:37. doi: 10.1186/s13098-016-0153-5. eCollection 2016.

    PubMed 27274772

  • Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.

    PubMed 24176437

  • Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229.

    PubMed 25275271

  • Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbol J, Moses AC, Buse JB, Tuttle RM; LEADER Trial Investigators. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Diabetes Obes Metab. 2015 May;17(5):477-86. doi: 10.1111/dom.12444. Epub 2015 Feb 23.

    PubMed 25656058

  • Steinberg WM, Buse JB, Ghorbani MLM, Orsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5.

    PubMed 28476871

  • Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornoe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011.

    PubMed 28854085

  • Hegedus L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbol JD, Daniels GH; LEADER Publication Committee on behalf of the LEADER Trial Investigators. No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial. Diabetes Care. 2018 Mar;41(3):620-622. doi: 10.2337/dc17-1956. Epub 2017 Dec 26.

    PubMed 29279300

  • Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Treppendahl MB, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial). Am J Cardiol. 2018 Jun 15;121(12):1467-1470. doi: 10.1016/j.amjcard.2018.02.030. Epub 2018 Mar 15.

    PubMed 29627109

  • Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Marso SP, Nauck MA, Poulter NR, Pratley RE, Zinman B, Michelsen MM, Monk Fries T, Rasmussen S, Leiter LA; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Circulation. 2018 May 15;137(20):2179-2183. doi: 10.1161/CIRCULATIONAHA.118.033898. No abstract available.

    PubMed 29760228

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 428 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 428 sites in United States, Brazil, Germany, United Kingdom, Canada and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (time frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01179048, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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